The STREAM Percutaneous Coronary Intervention Anticoagulant Sub-study

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of Enoxaparin and Unfractionated Heparin in St Elevation Myocardial Infarction patients undergoing primary percutaneous coronary intervention.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Robert Welsh
• Collaborators: Boehringer Ingelheim; Sanofi
• Treatments: Calcium heparin; Enoxaparin; Heparin

Criteria

Inclusion Criteria:

1. Age equal or greater than 18 years

2. Onset of symptoms of STEMI < 3 hours prior to randomisation

3. 12-lead ECG (ST elevation will be measured from the J point) indicative of an acute STEMI: >2 mm ST elevation across 2 contiguous precordial leads (best 2 of V1-V6) or leads I, AVL for a minimum combined total of >4 mm ST elevation,or >3 mm ST elevation in 2 contiguous inferior leads (best 2 of II, III, AVF) for a minimum combined total of > 6 mm ST elevation.

4. Informed consent received

Exclusion Criteria:

1. PCI (1st balloon inflation) expected to commence < 60 minutes from diagnosis (qualifying ECG) or inability to arrive at the cardiac catheterization laboratory (1st balloon inflation) within 3 hours after randomisation.

2. Anticipated or obvious problem with vascular access.

3. Previous CABG

4. Left bundle branch block or ventricular pacing.

5. Patients with cardiogenic shock - Killip Class 4

6. Patients with a body weight < 55 kg (known or estimated)

7. Uncontrolled hypertension, defined as blood pressure measurement > 180/110 mm Hg (systolic BP > 180 mm Hg and/or diastolic BP > 110 mm Hg) confirmed on repeat measures (2 documented measurements at any time) prior to randomization.

8. Known use oral anticoagulants (warfarin or coumadin) or GP IIb/IIIa antagonists within the preceding 7 days or recent administration of any IV or SC anticoagulation within 12 hours including: unfractionated heparin, enoxaparin, and/or bivalirudin.

9. Active bleeding, known bleeding diathesis/disorder including thrombocytopenia or clinical diagnosis associated with increased risk of bleeding including: known active peptic ulceration and/or neoplasm with increased bleeding risk.

10. Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI)

11. Any history of central nervous system abnormality (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e <3 months)

12. Any known history of haemorrhagic stroke or stroke of unknown origin

13. Ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months

14. Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 weeks

15. Known acute pericarditis and/or subacute bacterial endocarditis

16. Known acute pancreatitis or known severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis

17. Chronic dialysis or known renal insufficiency (prior S-creatinine >2.5 mg% (>220 µmol/l) for men and >2.0 mg% (>175 µmol/l)) for women

18. Pregnancy or lactation or parturition within the previous 30 days; women of childbearing potential must be using a medically accepted method of birth control

19. Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days

20. Known hypersensitivity to tenecteplase, alteplase, ASA, clopidogrel, enoxaparin, or to any of the excipients or to the contrast media used in angiography Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated